Resuscitation device and method of making the same

ABSTRACT

A manually manipulated resuscitation mask, which includes a flexible barrier for providing a sealing contact with a face of a victim in a region adjacent to a victim&#39;s mouth. The flexible barrier has an opening therethrough to cooperate with the victim&#39;2 mouth. The opening in the sheet us comprised of an integrally connected, flexible sleeve, extending away from the flexible sheet and the victim&#39;s face. The sleeve has an open end remote from where the sleeve is integrally connected to the flexible barrier sheet. The mask also includes a tubular member that has first and second end portions. The tubular member is positionable within the flexible sleeve and has the first end portion integrally secured to the open end of the flexible sleeve. The second end portion of the tubular member is located adjacent to the flexible barrier sheet when the tubular member is positioned within the sleeve. The sleeve and tubular member allow a mouth of a rescuer, when engaging the flexible sleeve and tubular member, to deliver air from the lungs and mouth of a rescuer to and through the tube to the mouth of the victim. A one-way-valve and a filter or combination thereof are fitted into the tubular member. 
     The tubular member is manually movable such that the second end portion of the tubular member may extend through the flexible sheet to engage a mouth of a victim.

This application is a division of my co-pending prior U.S. patentapplication Ser. No. 09/270,899 filed Mar. 15, 1999, now U.S. Pat. No.6,209,537 the benefit of which filing date is claimed under 35 U.S.C.120.

FIELD OF INVENTION

Mouth-to-mouth resuscitation devices of the type having a one-way valvethrough which air is delivered from a resuscitator's mouth to a victim'smouth and lungs through the valve.

BACKGROUND OF THE INVENTION

The effective use of mouth-to-mouth resuscitation devices often dependsupon how easy it is for a user of the device to be trained in its use.Classes in cardiopulmonary resuscitation often include ordinary citizenswith no paramedical background as well as individuals in training forpositions as paramedics. Equipment available for training ranges fromthose rare settings in which anatomically correct mannequins areprovided to practice pulmonary resuscitation, to those settings where amannequin's head resembles a human head and face only in that there issuggestion of facial feathers. The heads are normally formed of hard,hollow plastic. These suggested features usually include raised portionsrepresentative of a nose and forehead. Indentations may appear whereeyes would be located and a small circular or oval opening is providingto simulate a mouth. More often than not the mannequin's head size morenearly matches an average adult head rather than a child or infant.Among the most popular resuscitation masks in industrial and commercialsettings are those that include a physical shield between a rescuer anda victim requiring mouth-to-mouth resuscitation. The shield frequentlytakes the form of a flexible sheet having a centrally formed opening anda rigid tube secured to the sheet around the periphery of the opening.The rigid tube is intended to fit within a victim's mouth. The tuberoutinely includes a one-way valve to allow breath exhaled by therescuer to pass through the tube/one-way valve and into the mouth andlungs of the victim. The one-way valve and shield act to prevent exhaledor regurgitated matter of the victim from entering the mouth of therescuer.

Typical of such devices is that shown and described in Eisenberg et al.U.S. Pat. No. 4, 819, 628 ('628) issued Apr. 11, 1989, which shows anddescribes a device that includes a flexible sheet having an openingcentrally formed therein and a rigid tube secured to the sheet aroundthe periphery of the opening for insertion into a mouth of a victim. Aself-closing one-way valve is contained in the tube and extends downwardfrom the sheet opening.

A highly enhanced version of a resuscitation mask that also includes aflexible sheet with rigid tube located and secured into the flexiblesheet in a similar fashion to the '628 patent is applicant's own doubleshield mouth-to-mouth resuscitator mask with a barrier for contaminatedfingers, namely Baldwin U.S. Pat. No. 5,664,559 ('559) issued Sep. 9,1997. This patent distinguishes over the '628 patent in that there isprovided a second flexible barrier in the form of a thin sheet offlexible material that has an opening the periphery of which is securedto a first flexible barrier and a rigid tube containing a one-way-valveto thereby provide a spatially separated region between the first andsecond barriers to thereby isolate the mouth and face of the operatorfrom the area where the operator's fingers/hands make contact on thefirst flexible barrier.

Another resuscitation mask of this type is shown and disclosed inapplicant's co-pending patent application Ser. No. 09/128,112, filedAug. 3, 1998, titled Resuscitation Device with Instantly Closing Valve.A unique aspect of this invention resides in the employment of aflexible sleeve integrally secured to a flexible barrier sheet. At anoutlet end of the flexible sleeve, the sleeve has fashioned therein arigid member to create a one-way valve against the rigid member. Theflexible sleeve is stretched to open the one-way valve when air isdelivered to an inlet opening of the sleeve and then to and through thesleeve and past a flexible seal of the one-way valve. Positive, instantclosing is provided when air is no longer delivered to the insetopening. The invention just described provides a resuscitation devicefree of a valve housing, thereby allowing the device to be folded into aflat configuration to be readily carried in a billfold, thus encouragingits use by laymen.

In training situations both instructor and trainee are faced with thereality that the rigid tube that is normally inserted into a victim'smouth must now be inserted into the circular or oval mouth opening ofthe mannequin's head. Rarely is the mannequin mouth opening of a sizethat adequately accommodates the rigid tube. It is not uncommon for theattempted application of the mask to the mannequin's face to result inthe rigid tube secured to the flexible barrier to buckle in the regionwhere the tube joins the barrier. When this happens, the tube openingthat is intended to engage the mannequin's mouth opening topples ontoits side, making it nearly impossible for the instructor or rescuer intraining to place his/her mouth in the opposite side of the barrier andover the other end of the tube.

it is not surprising to find that instructors favor less effectiveresuscitation masks for certain kinds of mannequin's that do not haveany part thereof that enter the mouth when in use.

The subject invention avoids all these problems by recognizing that therigid tube must be secured to the flexible barrier by a means thatallows the rigid tube to remain perpendicular to the flexible barrierand/or mouth region of a mannequin or victim where the victim's mouthcan only be partially opened. The mask incorporating the subjectinvention not only provides a rigid tube covered by a sleeve portion ofthe flexible barrier that may engage a partially open mouth of a victim,while simultaneously converting to a mask with the rigid tube extendingtoward the victim's face by the simple application of a force pressingon the tube toward the face of the victim as the mask is about to beplaced on a victim's face.

SUMMARY OF THE INVENTION

The invention is directed to a mouth-to-mouth, manually manipulatedresuscitation mask, which includes a flexible barrier for providing asealing contact with a face of a victim in a region adjacent to a mouthof a victim. The flexible barrier is comprised of a thermoplastic sheethaving an opening therethrough to cooperate with a mouth of a victim.The opening in the sheet is comprised of an integrally connected,flexible sleeve, extending away from the flexible sheet and the victim'sface. The sleeve has an open end remote from where the sleeve isintegrally connected to the flexible barrier sheet. The mask alsoincludes a tubular member that has first and second end portions. Thetubular member is positionable within the sleeve and has the first endportion integrally secured to the open end of the sleeve. The second endportion of the tubular member is located adjacent to the flexiblebarrier sheet when the tubular member is positioned within the sleeve.The sleeve and tubular member as just described are readily available toengage a mouth of a rescuer to deliver air from lungs and mouth of arescuer to and through the tube to the mouth of a victim. Typically aone-way-valve and a filter or combinations thereof are fitted into thetubular member.

The tubular member is manually moveable such that the second end portionof the tubular member may extend through the flexible sheet to engage amouth of a victim, while simultaneously allowing their lips to pressagainst the flexible sheet to seal the sheet against the victim's face.

The invention further contemplates the inclusion of a method to producethe manually manipulated resuscitation mask. In a preferred embodimentthe method involves differential pressure forming a resuscitation maskof the type that may include a one-way valve and does include athermoplastic flexible barrier sheet hermetically secured to a tubularmember through which air is delivered from a rescuer's mouth to avictim's mouth and lungs.

The method is comprised of the following steps which include placing thetubular member in engagement with a porous plate such that a centralaxis of the tubular member is essentially perpendicular to the porousplate.

The next step involves locating the thermoplastic, flexible barriersheet between the tubular member and a source of heat, followed byactivating the source of heat to soften the thermoplastic flexiblebarrier sheet.

This step is succeeded by establishing a low-pressure region on a sideof the porous plate opposite to the porous plate side on which thetubular member has engaged the porous plate. The low pressure regionthereby causes a differential pressure across the porous plate thatresults in the softened thermoplastic flexible barrier sheet being drawntowards the tubular member and taking on a new shape, such that at leasta portion of the tubular member becomes sandwiched between the softenedflexible sheet and the porous plate.

The softened thermoplastic flexible barrier sheet is the cooled tothereby cause the flexible thermoplastic sheet to maintain it's newshape. Thereafter an opening is created through the flexible sheet in aregion where the surface of the flexible sheet is defined by the tubularmember.

The final step involves inserting into the tubular member, through theopening in the flexible thermoplastic sheet, an insert. The insert mateswith the flexible sheet to help secure the flexible sheet to the tubularmember. It is therefor a primary object of this invention to provide aresuscitation mask which easily allows a user of the mask to adjust avictim's mouth-engaging portion of the mask such that the mask mayengage a face surface of a victim or physically enter an open mouth.

Another object of the invention is to provide an adjustableresuscitation mask that cooperates effectively with a wide variety ofthe mouth openings found in training mannequins.

Yet another object of this invention is to provide a simple differentialpressure forming method for creating an adjustable resuscitation mask.

BRIEF DESCRIPTION OF THE DRAWINGS

The description set forth above, as well as other objects, features andadvantages of the present invention, will be more fully appreciated byreferring to the detailed description and the drawings that follow. Thedescription is of the presently preferred, but nonetheless illustrative,embodiment in accordance with the present invention, when take inconjunction with the accompanying drawings wherein:

FIG. 1 is a schematic arrangement of components involved in thedifferential pressure forming of a resuscitation mask that incorporatesthe invention;

FIG. 2 depicts a flexible thermoplastic barrier sheet in a softenedstate;

FIG. 3 shows the effect of a differential pressure environment on thearrangement of FIG. 2;

FIG. 4 illustrates a way to create an opening in a recessed region of athermoplastic sheet;

FIG. 5 depicts a manner of installing an insert in the form of a collarinto an opening in the thermoplastic sheet of FIG. 4;

FIG. 5a is a partial section of an insert of FIG. 5 fitted with aone-way valve and a filter;

FIG. 6 is a three dimension graphic of a resuscitation mask embodyingthe invention with a portion removed to reveal the details of thearrangement;

FIG. 7 is a cross-section of a resuscitation mask embodying theinvention where the mask tubular member has been moved to anotheroperating;

FIG. 8 is a three dimensional illustration of the mask arrangement ofFIG. 7;

FIG. 9 is a schematic representation of a training mannequin head;

FIG. 10 is a side view of the training mannequin head of FIG. 9 alongwith a prior art resuscitation mask in place; and

FIG. 11 is a side view of the training mask of FIG. 9 with resuscitationmask that embodies the invention in place on the mannequin face.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Reference is now made to FIG. 1, which depicts in a schematicillustration the basic components needed to make and practice thesubject invention. Centrally disposed in FIG. 1, a thermoplasticflexible barrier sheet 18 is shown midway between a controllable heatingunit 11 and a differential pressure creating arrangement 10. Thisarrangement 10 includes a porous plate 27, which is made porous byapertures such as passages 28, 29, 33, 34, and 35, five of which arereferenced. This plate 27 may also be termed a support means. Beneathporous plate 27 is what will be termed a vacuum chamber 31. The vacuumchamber 31 has a vacuum chamber wall 32, which engages the porous plate27 as shown. A vacuum pump 36 and its related vacuum pump control 37, asreferenced in FIGS. 1, 2, and 3, are connected via a vacuum pump duct38, as shown. It will be noted that centrally disposed on the porousplate surface 30 are a pair of locator pins, 25, 26, shown in crosssection. The detailed nature of these locator pins 25, 26, and themanner in which they are secured to or are part of the porous plate 27do not form a part of the instant invention. These locator pins 25, 26do act, however, to centrally locate on the porous plate 27 a tubularmember 21. It is this tubular member 21 that will ultimately provide anopen passage 22 for the flow of air from a rescuer's mouth to that of avictim, all in a manner to be described more fully later. The tubularmember 21 has a first end 23, which a later description will revealengages a rescuer's mouth. The tubular member 21 also has a second end24, which is shown centered on locator pins 25, 26, on the surface 30 ofthe porous plate 27. It is this second end 24 of the tubular member 21that will, in a fully formed resuscitation mask, engage a mouth of avictim to be resuscitated.

At the very top of FIG. 1 there is shown a heating unit 11 and relatedpower supply 12, connected by a lead 13 to the heating unit 11. A seriesof jagged arrows 16, 17, two of which are referenced and are shownextending downward from the heating unit 11. These jagged arrows areintended to convey visually the notion of radiant heat emanating fromthe heating unit 11 toward the thermoplastic flexible barrier sheet 18,shown immediately below in FIG. 1. On the left hand side of FIG. 1, in aspace between the thermoplastic flexible barrier sheet 18 and thesurface 30 of the porous plate 27, a reference character P₁ is shown.The character P₁ is intended to designate ambient air pressure in whichthe apparatus of FIG. 1 operates. Visually, directly beneath the ambientpressure character P₁ there will be seen a character P₂ located in thevacuum chamber 31. This character is intended to represent a pressurelower than ambient pressure P₁ brought about by activation of the vacuumpump 36 and it's related control 37. It is the difference in pressurebetween P₁ and P₂ that is hereinafter defined as the “differentialpressure” employed in the explanation of the method that embodies theinvention.

Reference is now made to FIG. 2, which is intended to show what happensto the thermoplastic barrier sheet 18 after the heating unit 11 has beenactivated for a time sufficient for the thermoplastic of which thebarrier sheet is composed, to soften. Note how the softenedthermoplastic barrier sheet 18 is shown draped over the porous plate 27and tubular member 21, all as indicated by reference numeral 41 andassociated arrow. In FIG. 2 pressures P₁ and P₂ are assumed to be equalin that the vacuum pump 36 and related control 27 have not beenactivated.

Attention is now directed to a study of FIGS. 2 and 3, which should beexamined together in conjunction with the explanation that follows. FIG.3 is intended to convey what happens when the vacuum pumps 36 andcontrol 37 have been turned on, thereby reducing the pressure P₂ in thevacuum chamber 31. When pressure P₂ falls below the ambient pressure P₁the thermoplastic flexible barrier sheet 18 in its softened and drapedstate, as shown in FIG. 2, is now drawn down onto the tubular member 21and the porous plate 27 in the manner depicted. It should also beappreciated that the invention may be practiced by removing the passages33, 34, 35 from the porous plate 27. When these passages are removed,the thermoplastic flexible sheet will nestle, that is, to settle snugly,into the tubular member 21. The sheet 18 will remain snug, much likethat shown in FIG. 2. However, a seal will exist where the flexiblesheet 18 engages the tubular member 21. When attention is directed to apreferred embodiment of the invention as shown in FIG. 3, andspecifically to the tubular member 21, it will be observed that thesoftened and now differential pressure drawn thermoplastic barrier sheet18 has moved toward and then around the tubular member 21, and has takenon a new shape, as shown. The new shape is one, which sandwiches thetubular member 21 between the sheet 18 and the porous plate 27. This newshape may be characterized as one in which there is now present a sleeve19 that now surrounds the tubular member 21. It is also apparent thatthere is now a portion of the thermoplastic flexible sheet 18 that hasbeen drawn into the tubular member 21 to form a recessed surface 20.

FIG. 3 is also intended to convey what takes place when the heating unit21 and vacuum pump 36 are idled and the entire apparatus is allowed tocool.

It should also be appreciated that the invention also contemplates thatin another embodiment there be no differential pressure and thethermoplastic flexible barrier sheet 18, when softened, will simply bedrawn by the force of gravity toward the tubular member. When thisoccurs, the softened thermoplastic flexible sheet 18 will take on a newshape, such that at least portion of the tubular member 21 becomessandwiched between the softened flexible sheet and the plate 27, whichacts as a support means.

Turning now to FIG. 4 there is shown a fully cooled and formedresuscitation mask. Centrally disposed in this figure and shown inbroken outline above the tubular member 21 and its central opening 22 isa cutting blade 34 with arrow 35 indicating the direction of travel theblade 34 is to make to cut through the recessed surface, see FIG. 3, tocreate an opening through the thermoplastic flexible sheet 18.Immediately beneath the cutting blade 34 there is shown in full line thecutting blade 34 piercing the recessed surface 20.

A glance at FIG. 5 reveals that positioned in a space at the top of thisfigure there is shown in broken a line a representation of aninsect/collar 44. An overall sense of the entire shape of thisinsert/collar 44 may best be appreciated by reference to FIG. 5, wheredirectly beneath the broken line representation of the inset/collar 44just noted, there is shown in solid line the insert/collar 44 positionedin place in the central opening 22. It will be noted that a solid linearrow 47 is shown passing through the broken line representation of theinsert/collar 44. The arrow 47 is intended to a convey a method step ofinserting the insert/collar 44 into the tubular member 21 through thecentral opening 22 in the tubular member and an opening created in therecessed surface 20, FIG. 4 of thermoplastic flexible sheet 18. When theinsert/collar 44 is pressed into place as shown in full line in thisfigure, there arises a seal between the tubular member 21, the flexiblethermoplastic sheet 18, where this sheet 18 enters the central opening22, and the insert/collar 44. When attention is focused on FIG. 5a of apartial section of an insert collar 44, it will be seen that there isincluded within the insert collar 44 a one-way valve 45 and a filter 46.The details of the one-way valve 45 and filter 46 do not form a part ofthe invention and are therefore not shown. Accordingly any suitablestate-of-the-art one-way valve and/or filter may be employed in thefinal product that embodies the invention.

FIG. 6 displays the resuscitation mask 55 with portions of the flexiblebarrier sheet 18 removed. An arrow 60 is intended to convey the ideathat when a force is applied to the tubular member 21 in the directionshown, the sleeve 19 and the mask 55 take on the general appearanceshown in FIGS. 7 and 8.

FIG. 9 is an outline of a mannequin's head 61 having a circular mouthopening 62. In FIG. 10 a prior art type of mask 63 is shownschematically disposed over the mannequin's mouth 62. The circularmannequin mouth openings are of such a size that the tubular member 64cannot fit within the circular opening 62. In situations where anindividual is being trained in the use of this type of resuscitationmask, the poor fit of the mask with the mannequin significantlydiminishes the reality of the simulated resuscitation attempt. FIG. 11shows a resuscitation mask 55 embodying the invention, fitted snuglyover the mannequin face. When a mask 55 embodying the invention is usedin training, the training experience most nearly simulates reality,which will produce a higher level of trainee confidence when thetraining is finished. While FIG. 11 depicts a mannequin head it willalso be appreciated that where a victim is an infant with a small mouthor an individual with teeth clenched shut, the resuscitation mask 55embodying the invention also finds great utility without being convertedto a more conventional configuration where the tubular member may beinserted into a victim's mouth. Inserting the tubular member into thevictim's mouth, when possible, has the advantage of acting as a biteclock, which aids in keeping the mouth open.

Though the invention has been described with respect to a specificpreferred embodiment thereof, many variations and modifications willimmediately become apparent to those skilled in the art. It is thereforethe intention that the appended claims be interpreted as broadly aspossible in view of the prior art to include such variations andmodifications.

What I claim as new:
 1. A method of differential pressure forming aresuscitation mask of the type that may include a one-way valve and doesinclude a thermoplastic flexible barrier sheet hermetically secured to atubular member through which air is delivered from a rescuer's mouth toa victim's mouth and lungs, said method comprised of the followingsteps: (a) placing said tubular member in engagement with a porous platesuch that a central axis of said tubular member is essentiallyperpendicular to said porous plate, (b) locating said thermoplasticflexible barrier sheet between said tubular member and a source of heat,(c) activating said source of heat to soften said thermoplastic flexiblebarrier sheet; (d) establishing a low pressure region on a side of saidporous plate opposite to the porous plate side on which said tubularmember has engaged said porous plate, said low pressure region therebycausing a differential pressure across said porous plate that results insaid softened thermoplastic flexible barrier sheet being drawn towardssaid tubular member and taking on a new shape such that at least aportion of said tubular member becomes sandwiched between said softenedflexible sheet and said porous plate, a portion of said softenedthermoplastic flexible sheet being drawn across said tubular member; (e)cooling said softened thermoplastic flexible barrier sheet to therebycause said flexible thermoplastic sheet to maintain its new shape; (f)creating an opening through said flexible sheet in a region where saidsurface is defined by the tubular member, and (g) inserting into saidtubular member through said opening in said flexible thermoplastic sheetan insert means that mates with said flexible sheet to form a sealbetween said tubular member, said flexible thermoplastic sheet and saidinsert means.
 2. The method claim 1 wherein said insert means includesintegral therewith a one-way valve.
 3. The method of claim 1 whereinsaid insert means includes a filter.
 4. The method of claim 2 whereinsaid insert means further includes a filter.
 5. A method of forming aresuscitation mask of the type that may include a one-way valve and doesinclude a thermoplastic flexible barrier sheet hermetically secured to atubular member through which air is delivered from a rescuer's mouth toa victim's mouth and lungs, said method comprised of the followingsteps: (a) placing a tubular member in engagement with a support meanssuch that a central axis of said tubular member is essentiallyperpendicular to said support means, (b) locating said thermoplasticflexible barrier sheet between said tubular member and a source of heat,(b) activating said source of heat to soften said thermoplastic flexiblebarrier sheet; (c) drawing said softened thermoplastic flexible barriersheet toward said tubular member placed on said support means to therebycover said tubular member and take on a new shape such that at least aportion of said tubular member becomes sandwiched between said softenedflexible sheet and said support means, and (d) cooling said softenedthermoplastic flexible barrier sheet to thereby cause said flexiblethermoplastic sheet to maintain its new shape; and (e) creating anopening through said flexible sheet in a region where said surface isdefined by the tubular member.
 6. The method of claim 5 wherein saidmethod further includes the step of: Inserting into said tubular memberthrough said opening in said flexible thermoplastic sheet an insertmeans that mates with said flexible sheet to form a seal between saidtubular member, said flexible thermoplastic sheet and said insert means.7. The method of claim 5 where the drawing of said softenedthermoplastic flexible barrier sheet toward said tubular member placedupon said support means is accomplished by having said support meanstake the form of a porous plate and causing a differential pressureacross said porous plate that results in said softened thermoplasticflexible barrier sheet being drawn toward said tubular member.
 8. Themethod of claim 5 where the drawing of said softened thermoplasticflexible barrier sheet toward said tubular member placed upon saidsupport means is accomplished by gravity.
 9. The method of claim 6wherein said insert means includes integral therewith a one-way valve.10. The method of claim 6 wherein said insert means further includes afilter.
 11. The method of claim 9 wherein said insert means furtherincludes a filter.